Regulatory Compliance Coordinator

3 days ago


Chicago, Illinois, United States MMS Full time
Job Summary:
MMS is a data-focused clinical research organization (CRO) seeking a highly skilled Regulatory Compliance Coordinator to provide operational support for clinical trial transparency. The ideal candidate will possess a strong background in regulatory requirements and excellent problem-solving skills.

The estimated salary for this position is $90,000 - $120,000 per annum, depending on experience and qualifications.

About the Role:
Clinical Trial Transparency involves providing high-quality deliverables in an efficient manner. Technical expertise on regulatory requirements (EMA Policy 0070, HC PRCI, EU-CTIS etc.) is essential. Facilitating the initiation, progression and completion of the exchange of information for all Transparency workflow steps requires skill and proficiency.

Responsibilities:
1. Provide high-quality transparency deliverables in a timely manner.
2. Ensure technical expertise on regulatory requirements (EMA Policy 0070, HC PRCI, EU-CTIS etc.).
3. Facilitate the initiation, progression and completion of the exchange of information for all Transparency workflow steps with minimal management oversight.
4. Perform quality control reviews of document redaction or anonymization to ensure consistency and accuracy.

Requirements:
1. Bachelor's Degree in a scientific, medical, or clinical discipline or related field is preferred; or 5 years of experience if less than a Bachelor's.
2. At least 3 years of previous transparency experience.
3. Hands-on experience with clinical trials and pharmaceutical development preferred.

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